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Early prediction of endocrine responsiveness in ER+/HER2-negative metastatic breast cancer (MBC): pilot study with 18F-fluoroestradiol (18F-FES) CT/PET.
Literature Information
| DOI | 10.1016/j.annonc.2024.02.007 |
|---|---|
| PMID | 38423389 |
| Journal | Annals of oncology : official journal of the European Society for Medical Oncology |
| Impact Factor | 65.4 |
| JCR Quartile | Q1 |
| Publication Year | 2024 |
| Times Cited | 9 |
| Keywords | (18)F-fluoroestradiol PET/CT, endocrine sensitivity, molecular imaging, randomized clinical trial, standardized uptake value (SUV) |
| Literature Type | Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial |
| ISSN | 0923-7534 |
| Pages | 549-558 |
| Issue | 35(6) |
| Authors | A Gennari, E Brain, A De Censi, O Nanni, R Wuerstlein, A Frassoldati, J Cortes, V Rossi, M Palleschi, J L Alberini, F Matteucci, A Piccardo, G Sacchetti, H Ilhan, F D'Avanzo, B Ruffilli, S Nardin, M Monti, M Puntoni, V Fontana, L Boni, N Harbeck |
TL;DR
The ET-FES trial assessed the use of 18F-fluoroestradiol (FES) PET/CT as a predictive biomarker for treatment response in estrogen receptor-positive, HER2-negative metastatic breast cancer, revealing that patients with a standardized uptake value (SUV) ≥ 2 had better outcomes with endocrine therapy (ET) compared to those with SUV < 2, who fared better with chemotherapy. These findings emphasize the importance of personalized treatment strategies based on endocrine responsiveness, highlighting the heterogeneity within this patient population.
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(18)F-fluoroestradiol PET/CT · endocrine sensitivity · molecular imaging · randomized clinical trial · standardized uptake value (SUV)
Abstract
BACKGROUND 18F-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) is considered an accurate diagnostic tool to determine whole-body endocrine responsiveness. In the endocrine therapy (ET)-FES trial, we evaluated 18F-FES PET/CT as a predictive tool in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC).
PATIENTS AND METHODS Eligible patients underwent an 18F-FES PET/CT at baseline. Patients with standardized uptake value (SUV) ≥ 2 received single-agent ET until progressive disease; patients with SUV < 2 were randomized to single-agent ET (arm A) or chemotherapy (ChT) (arm B). The primary objective was to compare the activity of first-line ET versus ChT in patients with 18F-FES SUV < 2.
RESULTS Overall, 147 patients were enrolled; 117 presented with 18F-FES SUV ≥ 2 and received ET; 30 patients with SUV < 2 were randomized to ET or ChT. After a median follow-up of 62.4 months, 104 patients (73.2%) had disease progression and 53 died (37.3%). Median progression-free survival (PFS) was 12.4 months [95% confidence interval (CI) 3.1-59.6 months] in patients with SUV < 2 randomized to arm A versus 23.0 months (95% CI 7.7-30.0 months) in arm B, [hazard (HR) = 0.71, 95% CI 0.3-1.7 months]; median PFS was 18.0 months (95% CI 11.2-23.1 months) in patients with SUV ≥ 2 treated with ET. Median overall survival (OS) was 28.2 months (95% CI 14.2 months-not estimable) in patients with SUV < 2 randomized to ET (arm A) versus 52.8 months (95% CI 16.2 months-not estimable) in arm B (ChT). Median OS was not reached in patients with SUV ≥ 2. 60-month OS rate was 41.6% (95% CI 10.4% to 71.1%) in arm A, 42.0% (95% CI 14.0% to 68.2%) in arm B, and 59.6% (95% CI 48.6% to 69.0%) in patients with SUV ≥ 2. In patients with SUV ≥ 2, 60-month OS rate was 72.6% if treated with aromatase inhibitors (AIs) versus 40.6% in case of fulvestrant or tamoxifen (P < 0.005).
CONCLUSIONS The ET-FES trial demonstrated that ER+/HER2- MBC patients are a heterogeneous population, with different levels of endocrine responsiveness based on 18F-FES CT/PET SUV.
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Primary Questions Addressed
- How does the standardized uptake value (SUV) of 18F-FES correlate with long-term outcomes in ER+/HER2-negative MBC patients?
- What alternative imaging modalities could complement 18F-FES PET/CT in assessing endocrine responsiveness in breast cancer?
- How might the findings of the ET-FES trial influence future clinical guidelines for treating ER+/HER2-negative metastatic breast cancer?
- What are the potential implications of varying endocrine responsiveness levels on personalized treatment strategies for breast cancer patients?
- In what ways could the results of this pilot study inform research on other biomarkers for predicting treatment efficacy in breast cancer?
Key Findings
1. Research Background and Objectives
The study investigates the predictive capabilities of 18F-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in identifying endocrine responsiveness in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). As endocrine therapy (ET) is a common treatment for ER+ MBC, accurately predicting which patients will benefit from it is essential for optimizing treatment strategies. The study aims to evaluate whether baseline 18F-FES PET/CT can serve as an effective predictive tool to differentiate between patients likely to respond to endocrine therapy versus those who may require chemotherapy.
2. Main Methods and Findings
In this pilot study, 147 eligible patients underwent baseline 18F-FES PET/CT imaging. Patients were categorized based on their standardized uptake value (SUV): those with SUV ≥ 2 received endocrine therapy, while those with SUV < 2 were randomized to receive either single-agent endocrine therapy (arm A) or chemotherapy (arm B). The primary endpoint was to compare the progression-free survival (PFS) and overall survival (OS) between the two treatment arms for patients with low SUV. The results showed that 73.2% of patients experienced disease progression, with significant differences in PFS and OS between treatment groups. Specifically, median PFS for arm A was 12.4 months versus 23.0 months for arm B. For patients with SUV ≥ 2, median OS was not reached, while for those with SUV < 2, median OS was markedly lower in arm A compared to arm B.
3. Core Conclusions
The findings indicate that the ER+/HER2- MBC patient population exhibits significant heterogeneity in endocrine responsiveness as determined by 18F-FES CT/PET SUV. Patients with SUV ≥ 2 demonstrate superior outcomes with endocrine therapy, showing a 60-month OS rate of 59.6%, compared to a lower rate in the SUV < 2 cohort, where outcomes were significantly improved with chemotherapy. Additionally, patients treated with aromatase inhibitors showed a markedly higher 60-month OS rate compared to those treated with fulvestrant or tamoxifen.
4. Research Significance and Impact
This study underscores the potential of 18F-FES PET/CT as a valuable tool in personalizing treatment for ER+/HER2- MBC patients. By identifying patients most likely to benefit from endocrine therapy, clinicians can tailor treatment plans to enhance patient outcomes and avoid unnecessary chemotherapy for those less likely to respond. Ultimately, this research could lead to improved survival rates and quality of life for patients with metastatic breast cancer, highlighting the importance of advanced imaging techniques in oncology decision-making. The study contributes to the growing body of evidence supporting precision medicine in cancer treatment.
Literatures Citing This Work
- Radiotracer Innovations in Breast Cancer Imaging: A Review of Recent Progress. - Mohamad Haidar;Joe Rizkallah;Omar El Sardouk;Nour El Ghawi;Nadine Omran;Zeinab Hammoud;Nina Saliba;Arafat Tfayli;Hiba Moukadem;Ghina Berjawi;Lara Nassar;Fahad Marafi;Partha Choudhary;Habibollah Dadgar;Alyaa Sadeq;Alain S Abi-Ghanem - Diagnostics (Basel, Switzerland) (2024)
- Novel Molecular Classification of Breast Cancer with PET Imaging. - Ngô Minh Toàn - Medicina (Kaunas, Lithuania) (2024)
- Predictive and prognostic value of 18F-FES PET/CT for patients with recurrent or metastatic breast cancer treated with endocrine therapy plus cyclin-dependent kinase 4/6 inhibitors. - Hyehyun Jeong;Jeongryul Ryu;Jae Ho Jeong;Sangwon Han;Jaewon Hyung;Jin-Hee Ahn;Kyung Hae Jung;Sung-Bae Kim;Byung-Kwan Jeong;Hee Jin Lee;Gyungyub Gong;Dae Hyuk Moon - European journal of nuclear medicine and molecular imaging (2025)
- [18F]F-FES PET for diagnosis, staging, and endocrine therapy prediction in ER-positive breast cancer: a systematic review and meta-analysis. - Ying Xu;Ru Yao;Zhixin Hao;Fangyuan Chen;Bowen Liu;Qiang Sun;Bo Pan;Li Huo;Yidong Zhou - EJNMMI research (2025)
- Evaluating Automated Tools for Lesion Detection on 18F Fluoroestradiol PET/CT Images and Assessment of Concordance with Standard-of-Care Imaging in Metastatic Breast Cancer. - Renee Miller;Mark Battle;Kristen Wangerin;Daniel T Huff;Amy J Weisman;Song Chen;Timothy G Perk;Gary A Ulaner - Radiology. Imaging cancer (2025)
- The Role of [18F]FES PET/CT in Breast Cancer Management: An Umbrella Review. - Marco Cuzzocrea;Rosa Di Micco;Giorgia Elisabeth Colombo;Stefania Maria Rita Rizzo;Gaetano Paone;Virginia Casati;Turki Alkhaldii;Fatemah Khajah;Claudia Rauh;Maggie Banys-Paluchowsky;Nina Ditsch;Thorsten Kuehn;Oreste D Gentilini;Giorgio Treglia;Maria Luisa Gasparri - Cancers (2025)
- 18F-fluoroestradiol (18F-FES) PET/CT for guiding first-line treatment in patients with HR + /HER2- metastatic breast cancer: impact on progression free survival. - Yizhao Xie;Yifan Chen;Cheng Liu;Yannan Zhao;Chengcheng Gong;Shuyi Lin;Shaoli Song;Biyun Wang;Zhongyi Yang - European journal of nuclear medicine and molecular imaging (2025)
- Resistance to neoadjuvant chemotherapy in breast cancers: a metabolic perspective. - Manon Desgres;Melis Poyraz;Buse Sari;François P Duhoux;Cédric van Marcke;Cyril Corbet - Journal of experimental & clinical cancer research : CR (2025)
- Could 18F-FES PET Be a New Driver in Therapeutic Choice for Metastatic HR+/HER2- Patients? - Maria Vita Sanò;Alessandro Russo;Lorenza Marino;Sarah Pafumi;Martina Di Pietro;Giuseppina Rosaria Rita Ricciardi - Diagnostics (Basel, Switzerland) (2025)
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